Darunavir + Omeprazole = Precautionary

Effect on Concentration

Darunavir
No change
Applies within class?
No
Omeprazole
Unknown
Applies within class?
No

Pharmacologic Effects

Effect
N/A
Applies within class?
No
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

A three-way cross-over study compared the effects of ranitidine and omeprazole on the pharmacokinetics of darunavir and ritonavir (DRV/r). Six gropus of healthy volunteers received the three following treatments, with 7-day wash-out periods between each treatment session: treatment A: DRV/r 400mg/100mg twice daily for 4 days, plus a morning dose on day 5; Treatment B: DRV/r 400mg/100mg twice daily and ranitidine 150mg twice daily for 4 days, plus a morning dose on day 5; Treatment C: DRV/r 400mg/100mg twice daily and omeprazole 20mg once daily for 4 days, plus a morning dose on day 5. There were no differences in Cmax or AUC of DRV plus ranitidine compared to DRV/r alone. The least squares mean ratios were Cmax, 0.96; AUC, 0.95. Co-administration of ranitidine had no effect on DRV Tmax. There was a slight increase in DRV Cmax and AUC when co-adminstered with omeprazole. The least squares mean ratios were Cmax, 1.02; AUC, 1.04. Co-administration of omeprazole had no effect on DRV

Sources

Study Design

Study Results

Study Conclusions

References

Vanitha J Sekar, Eric Lefebvre, Els De_Paepe, Tine De_Marez, Martine De_Pauw, Wim Parys, Richard MW Hoetelmans. Pharmacokinetic interaction between darunavir boosted with ritonavir and omeprazole or ranitidine in human immunodeficiency virus-negative healthy volunteers. Antimicrobial Agents And Chemotherapy. 2007; 3: 958-961.